September 07, 2010

September 7, 2010 (Stockholm, Sweden) — A host of new recommendations for the management of atrial fibrillation are included in the latest guidelines on the subject, issued last week at the European Society of Cardiology (ESC) 2010 Congress by the ESC [1]. Chair of the ESC task force for the management of AF, Dr A John Camm (University of London, UK), told heartwire that this is the first time that the Europeans have produced independent advice on AF; the previous guidelines were collated in conjunction with the AHA and ACC four years ago.

Dr A John Camm

Highlights of the new recommendations include the introduction of a symptom score for AF; the addition of "long-standing persistent AF" as a patient category; the adoption of risk profiling to assess who will benefit most from new anticoagulants to prevent stroke; new guidance in the area of rate control; advice on how to use the antiarrhythmic drug dronedarone (Multaq, Sanofi-Aventis); formal indications for the use of ablation therapy; recommendations on "upstream" therapies to prevent the deterioration of AF; and advice on certain "special situations."

"We estimate that around 1% to 2% of the population are affected by AF; it has become an epidemic," said Camm. "And this figure is expected to at least double, in line with the demographics of an aging population, because the condition is particularly prevalent among older people. We needed to create contemporary guidelines because of new drug therapies that are available and because of accumulating evidence on how to refine treatment regimens to obtain the best outcomes," he added.

Dr Gabriel Steg

Asked by heartwire to comment on the new guidelines, Dr Gabriel Steg (Hôpital Bichat-Claude Bernard, Paris, France), who was not involved in drafting them but who last week reported preliminary data from a new registry of more than 10 000 patients with atrial fibrillation, REALISE-AF, said: "These new recommendations appear simpler and more pragmatic. I hope having this approach will help popularize the guidelines, because I can understand that cardiologists and GPs might have had trouble remembering the complex algorithms for decision-making used in the past. We're moving in the right direction."

All New: EHRA Symptom Score, Another Category for AF, Risk Profiling

These new recommendations appear simpler and more pragmatic. We're moving in the right direction.

In an interview with heartwire , Camm outlined how the new guidelines--developed together with the European Heart Rhythm Association (EHRA) and endorsed by the European Association for Cardio-Thoracic Surgery (EACTS)--differ from the last recommendations on the management of AF, issued in 2006.

The ESC has introduced a new symptom score for arrhythmias, "like the NYHA class for heart failure," Camm explained. This score is called the EHRA score and "is designed to try to get a better description of a patient's symptomatic status, since much of the treatment of AF is symptom-dependent," he said.

Further, another category has been added to the classification of AF over and above the current ones: paroxysmal (AF lasting less than seven days); persistent AF (seven days to one year); and permanent AF. The new one, long-standing persistent AF--defined as AF lasting more than one year--was created because it was felt that this category of patient is a candidate for ablation therapy, Camm explained.

A third development was to establish better risk profiles for assessing the likelihood of stroke in patients with AF, he said. AF confers a fivefold increase in the risk of stroke if left untreated and a doubling of the risk of death from such strokes.

These changes have been made in anticipation that we are going to get safer and more effective anticoagulants soon.

Included is some refinement with regard to use of the CHADS2 score, with the advent of a new, "more sensitive system" called CHADS2-VASc, said Camm. "Although CHADS2 is easy to remember, it doesn't pick up some of the people who are in need of anticoagulation, so we've added in other risk factors," he explained. These include additional score points for specific age categories and for the presence of vascular disease and female gender. Also linked to this is a new score, HAS-BLED, for assessing bleeding risk. "These changes have been made in anticipation that we are going to get safer and more effective anticoagulants soon," he said.

Camm was referring to new oral anticoagulants for stroke prevention in AF that could be approved in coming months. The furthest ahead is the direct thrombin inhibitor dabigatran (Pradaxa, Boehringer Ingelheim), which is due to be considered by a US FDA advisory committee on September 20, 2010 for the prevention of stroke in patients with AF, based on the RE-LY megastudy.

Also in similar trials are the factor Xa inhibitors, rivaroxaban (Xarelto, Bayer/Johnson & Johnson) which is currently being tested for stroke prevention in the ROCKET-AF study, due to be reported at the American Heart Association meeting in November, and apixaban (Bristol-Myers Squibb/Pfizer), in a similar trial, called ARISTOTLE, with results expected next year. Another trial presented last week at the ESC meeting, AVERROES, showed that patients with atrial fibrillation and unable to take warfarin who were given apixaban had a significantly lower risk of stroke and systemic embolic events compared with similar patients treated with aspirin.

Changes to Rate and Rhythm Control, Formal Acceptance of Ablation

Another focus of the new guidelines is the recognition that AF is treated not only by cardiologists but also by specialists from many other branches of medicine, including geriatricians and primary-care doctors, said Camm, "So we have provided guidance for all levels of patient management."

In regard to rate control, Camm said: "We have introduced the notion that lenient rate control--that is, a resting heart rate of <110 bpm--is satisfactory and that we don't need to get resting heart rate to <80 bpm." This recommendation has been made on the basis of the RACE-2 trial, reported earlier this year, he noted.

For rhythm control, the guidelines incorporate the new antiarrhythmic drug dronedarone, which was approved by the European Medicines Agency at the end of last year, into the recommendations. "We're saying, from a benefit/risk point of view, that dronedarone is widely applicable," said Camm.

We're saying, from a benefit/risk point of view, that dronedarone is widely applicable.

Catheter ablation also gains a stronger footing as a treatment for AF in the new European guidelines. "We've given a formal indication for ablation therapy, which was implied but not formally recommended in the previous 2006 guidelines," Camm said. "Potentially provocative" is the suggestion that patients may have an ablation without previous trials of antiarrhythmic drugs if they have paroxysmal AF, no prior heart disease, or are unwilling to take antiarrhythmics, he says.

The task force also attempts to give advice on a number of "special situations." For example, in athletes with AF, it is recognized that treatment with drugs is often difficult, Camm noted, "so we've suggested ablation or a pill-in-the pocket approach, whereby the athlete takes an antiarrhythmic drug only if he or she has AF."

Finally, the recommendations give updated advice on so-called "upstream" therapy that may be prescribed in an attempt to prevent the deterioration of AF, covering the use of ACE inhibitors, angiotensin-receptor blockers (ARBs), and statins.

Disclosures for the authors and reviewers are available at www.escardio.org/guidelines.

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